Clinical Research Directory

Cor360: Clinician-Facing Broad-Spectrum Cardiac Phenotyping and Risk Assessment Using COR® Wearable ECG to Inform Outcomes-Oriented Care Pathways

Cor360 is an observational study evaluating whether extended wearable electrocardiogram (ECG) data can support broad-spectrum cardiac phenotyping and risk assessment beyond conventional single-purpose ambulatory rhythm monitoring. The study evaluates a clinician-facing, AI-enabled decision-support system that analyzes data from the Cor XT and Cor MDx wearable ECG devices and organizes patient-specific findings into an integrated Cor360 report for review by qualified clinicians. Rather than focusing only on detection of arrhythmias, Cor360 evaluates multiple dimensions of cardiovascular physiology and disease simultaneously. The active Cor360 indication panel may include more than 150 reportable findings or sub-findings organized across six clinically oriented pathways: Structural, Functional, Conductance, Hemodynamic, Neurohormonal/Autonomic, and Atrial Fibrillation/Ventricular Arrhythmia/Sudden Cardiac Death. Depending on the ECG data available for an individual participant, Cor360 may characterize findings and risk markers related to left ventricular hypertrophy and atrial enlargement; heart-failure phenotype and ejection-fraction-related abnormalities; conduction delay and heart block; repolarization and ischemia-related abnormalities; atrial fibrillation and atrial substrate; ventricular ectopy, nonsustained ventricular tachycardia and electrical-instability markers; syncope mechanisms; and selected ECG-derived hemodynamic and structural/functional surrogates. The platform may also evaluate autonomic regulation and heart-rate variability, cardiopulmonary coupling, sleep-disordered breathing and obstructive sleep apnea screening indicators, electrolyte-related ECG abnormalities, and other clinically relevant physiologic patterns. Cor360 is designed to move from isolated ECG findings toward multidimensional cardiac phenotyping and multi-pathway risk assessment. Individual findings may be combined into clinically meaningful phenotypes and risk profiles, such as atrial-fibrillation-prone substrate, heart-failure-related autonomic or repolarization profiles, ventricular electrical-instability patterns, ischemia-related risk signals, or sleep-disordered-breathing-related cardiovascular burden. Where repeated ECG studies are available, Cor360 may also assess changes in cardiac phenotype, physiologic state, and risk trajectory over time. Reports are individualized rather than identical across participants. Only indications supported by the participant's available data, signal quality, monitoring duration, and applicable analysis criteria are presented. Longer-duration recordings may support deeper assessment of autonomic function, sleep-related physiology, intermittent abnormalities, and longitudinal risk patterns. Cor360 also evaluates whether an extended wearable ECG record can support cross-domain clinical synthesis rather than requiring each physiologic signal to be interpreted in isolation. When appropriate, reports may link detected phenotypes and risk markers to guideline-informed care-pathway considerations while identifying uncertainty, data-quality limitations, and findings that are not reportable because monitoring-duration or signal criteria are not met. The primary objective of the study is to determine whether clinicians judge Cor360 reports to provide clinically actionable cardiac phenotyping or risk-assessment information. The study will also evaluate whether reviewing a Cor360 report changes, refines, or confirms a clinician's assessment or intended care pathway, and how Cor360 findings agree with available clinical reference information, standard-of-care testing, or independent expert review. The study includes adults 18 years of age or older with completed or planned Cor XT or Cor MDx wearable ECG monitoring. It includes retrospective and prospective single-study assessments, longitudinal repeated-study assessments, combined retrospective/prospective analyses, and selected limited-duration streaming or patient-activated event assessments. The protocol spans real-world acquisition settings, including home, clinic, ambulatory care, emergency department/triage, ambulance or transport, hospital-based, and hybrid clinic-to-home workflows. Where suitable reference information is available, Cor360 findings may be compared with 12-lead ECG interpretation, Holter or ambulatory ECG findings, echocardiography, other imaging, laboratory results, sleep testing, clinical diagnosis, or blinded expert-panel review. Cor360 is being evaluated as a clinician-facing decision aid and not as an autonomous diagnostic system. Its outputs are intended to augment clinical interpretation and support consideration of relevant care pathways, including rhythm management, heart-failure evaluation, ischemia assessment, conduction or pacing evaluation, and sleep-apnea work-up. The clinician remains responsible for diagnosis, treatment, testing, referral, and patient management.

Mitral Valve Edge-to-Edge Repair in Patients With Exercise-Induced Severe Mitral Regurgitation

The goal of this clinical trial is to learn whether mitral valve transcatheter edge-to-edge repair (TEER) in addition to guideline-directed medical therapy (GDMT) can improve clinical outcomes and symptoms in heart failure patients with non-severe secondary mitral regurgitation (SMR) at rest and exercise-induced severe SMR. The main questions it aims to answer are: * Does mitral valve TEER in addition to GDMT lead to better overall clinical outcomes than GDMT alone in patients with heart failure and exercise-induced severe SMR? * Does mitral valve TEER reduce the risk of death, heart failure hospitalization, or worsening SMR during 12 months of follow-up compared with GDMT alone? * Does mitral valve TEER improve patients' quality of life compared with GDMT alone? Participants will: * Undergo screening assessments to confirm eligibility for the study. * Be randomly assigned to receive either GDMT alone or GDMT plus mitral valve TEER. * Attend follow-up visits at approximately 3 time points during a 12-month follow-up period. * Undergo clinical evaluations that are routinely performed in patients with heart failure and SMR, including assessment of symptoms, functional status, and cardiac function. The patients' echocardiographic data will undergo an additional centralized assessment by an independent Core Laboratory.

Safety and Effectiveness of Left Bundle Branch Area Pacing Versus Conventional Cardiac Resynchronization Therapy in Heart Failure

This study will compare two different methods to pace the heart to treat heart failure including: 1. The current standard method of implanting a pacing lead in a vein on the surface of the left lower chamber of the heart (left ventricle) to deliver heart failure therapy. This method is called Cardiac Resynchronization Therapy (CRT). 2. The other method is using a lead implanted in the Left Bundle Branch Area (LBBA) of your heart. This method is called Left Bundle Branch Area Pacing or LBBAP. This lead is approved by the Food and Drug Administration (FDA) to be implanted in this area of the heart, but not to provide heart failure treatment.

AI-Optimized Single-Feature Recognition Model for Heart Failure

This prospective, single-center and observational study aims to develop and validate the single-feature artificial intelligence algorithm based on data collected via the wearable ECG patches in patients with heart failure (HF). The main question: Does the algorithm, using synchronized ECG and accelerometer signals from the ECG patches, achieve accurate detection of heart sounds (S1, S2, and in some patients S3, S4) compared with the Eko CORE 500 digital stethoscope in patients with acute exacerbation of HF? It aims to answer: Participants with confirmed HF (NYHA classification II-IV) will first undergo a 2-minute session of simultaneous ECG patches and digital stethoscope recordings, followed by standard 12-lead ECG, and then the repeated ECG patches and 2-minute heart sound recording session. Data will be used for algorithm training and validation. The primary endpoint is the accuracy of heart sound detection via the Vivalink ECG patches compared with the Eko CORE 500 digital stethoscope.

REstoration of SYNChronous Cardiac Function Due to Physiologic cArdiac Pacing Modalities With Clinical Endpoints

The goal of this observational study is to evaluate the long-term clinical outcomes of physiologic cardiac resynchronization therapy (CRT) using conduction system pacing strategies compared with conventional biventricular CRT in patients with heart failure with reduced ejection fraction (HFrEF) and electrical dyssynchrony. The main questions it aims to answer are: * Does physiologic CRT (including left bundle branch area pacing \[LBBAP\] and LBBAP-optimized CRT) reduce the combined risk of all-cause mortality and heart failure hospitalization compared with conventional biventricular CRT? * Does physiologic CRT improve cardiac function and reverse ventricular remodeling more effectively than conventional CRT? Participants receiving physiologic CRT as part of routine clinical care will undergo standard follow-up evaluations, including electrocardiography, echocardiography, laboratory testing, and device interrogation. Clinical outcomes will be collected prospectively for 24 months and compared with a historical cohort of patients treated with conventional biventricular CRT. The study will assess clinical outcomes, echocardiographic response, electrical resynchronization parameters, and device-related safety in a real-world heart failure population.

Ted Rogers Understanding of Exacerbations in Heart Failure 2: Monitor

Heart Failure (HF) is a complex disease associated with the highest burden of cost to the healthcare system. The cardiopulmonary exercise test (CPET) is instrumental in determining the prognosis of patients with HF. This multicentre study will validate whether aggregate biometric data from the Apple Watch combined with demographic, cardiac, and biomarker testing can improve our ability to predict heart failure outcomes among a diverse outpatient HF population.

An Optimization Pilot to Optimize An Early Palliative Care Intervention for Advanced Heart Failure

Using a highly innovative methodology, the Multiphase Optimization Strategy (MOST), the purpose of this randomized factorial pilot trial is to identify feasibility, acceptability, and preliminary efficacy of components of an intervention (UPHOLDS) to improve quality of life of older adults with advancing heart failure. Using a 2x2x2x2 factorial design, 64 adults with advancing heart failure will be randomized to receive one or more palliative care coach-delivered components, based on Ferrans' Health-Related Quality of Life Model: 1) psychoeducation on palliative care principles (4 vs. 8 sessions); 2) financial coaching (yes vs. no); 3) one-time specialty outpatient palliative care consultation (yes vs. no); and monthly follow (1 monthly follow-up call vs. monthly follow-up calls for 24 weeks).

Peripheral Drivers of Heart Failure Progression - The Prospective PEDAL-HF Study

PEDAL-HF is a registry-based randomized prospective multicenter study. The investigators plan to include 1000 patients who were recently admitted with acute decompensated heart failure at five tertiary heart clinics in Germany. For the randomised part, 750 patients will be randomized to care within a heart failure network or usual care. The primary endpoint of the randomized trial is change in NT-proBNP from baseline to 6 months of follow-up. All patients (randomized or not) will be followed for two years.

Urine Sodium-Driven Diuretic Adjustment Strategy in Acute Decompensated Heart Failure

The goal of this clinical trial is to learn if increasing the dose of diuretics to achieve a higher urine sodium target produces better clinical results when treating patients hospitalized with acute heart failure when compared to lower urine sodium target and standard of care. The main questions it aims to answer are: 1. Does targeting a higher urine sodium goal achieve greater natriuresis and diuresis? 2. Does targeting a higher urine sodium goal reduce frequency of hospital readmissions? 3. Does targeting a higher urine sodium goal reduce hospital length of stay? Researchers will compare natriuresis-guided arms with standard of care to see if targeting higher natriuresis goals improves significantly over current practice. Participants will submit urine samples at routine intervals after being given diuretics to evaluate urine sodium concentration. If urine sodium is low then diuretic dose will be increased.

Remote Monitoring of Cardiac Mechanics in Heart Failure Patients

Heart failure is a severe heart disease, where the heart's ability to pump blood is unsatisfactory. The consequence is a high risk of hospitalization and death. Heart failure is treated with medicine which relieves symptoms and slows down the disease progression. This medical treatment needs routine adjustment, but in many cases, this adjustment is not done timely, which results in life treating conditions where the patients need acute hospitalization. Remote health monitoring of HF patients has the potential to ensure timely adjustment. However, only sensors placed inside the blood vessels of the lung, have been shown effective. The disadvantage is that the placement of the sensor requires surgery. This makes the method costly and poses a risk for the patient. The aim of the current project is to develop a small intelligent patch, which can measure the heart's function from the outside of the body. The method will be low-cost, simple to use and will not pose a risk to the patient.

Evaluation of Liver Stiffness Performance, by FibroScan®, to Detect Elevated Central Venous Pressure (CVP)

This is a pivotal, global, prospective, cross-sectional, multicentric clinical investigation designed to explore a non-invasive, reliable alternative to invasive, catheter-based hemodynamic assessments, which are associated with procedural risks and limited applicability in certain participant populations.

Cardiovascular Performance and Exercise Response in Patients With Persistent or Permanent Atrial Fibrillation and Heart Failure Pre and Post Cardioversion or Pace and Ablate

Heart Failure (HF) and Atrial Fibrillation (AF) are two conditions that commonly occur together. Clinical guidelines consider a resting heart rate of 100-110 beats per minute (bpm) acceptable for patients with HF and AF while 72 bpm is considered the average in healthy populations. A higher resting heart rate indicates that the heart is working harder to meet bodily demands, and though it may be considered safe for patients with HF and AF to have a heart rate of 110 bpm, the investigators believe it is having a significant negative impact on patient quality of life and their ability to exercise. The current study will test exercise ability using a treadmill test before and after either a cardioversion, where the patient's heartbeat is reset using electric shocks, or a pace and ablate method, where the patient receives a pacemaker to regulate their heart rhythm and an ablation (intentional damaging) of the node that coordinates the beats within the heart. This will allow investigators to compare how the heart responds to exercise when the patient is on rate-control and anticoagulation medication therapy (before cardioversion or pace and ablate) and after the procedures. During exercise, the investigators will do a blood test that lets investigators know how efficiently the heart is working and record any symptoms experienced. The investigators will also collect information about the patient's quality of life. Using this information, the investigators hope to better understand whether the current standard of a resting heart rate of 100-110 bpm is ideal for patient quality of life.

Effects of a 20-Minute Mindfulness-Based Breathing Exercise on Dyspnea, Fatigue, and Sleep Quality in Patients With Heart Failure

Heart failure (HF) is a chronic condition that leads to incapacity. Despite significant progress in optimizing pharmacological treatment for HF patients, the personal and social burden of this disease is still characterized by debilitating symptoms and rehospitalizations. Today, many patients with heart failure use non-pharmacological methods for managing common symptoms. Due to the increased interest in non-pharmacological methods among individuals in society, it has become essential for healthcare professionals, including nurses as part of the healthcare team, to play a role in these methods to meet the health needs of the community. One of the interventions nurses can offer for symptom management is mindfulness-based breathing exercises. In this mind-body-based practice, attention is focused on the breath, helping individuals develop awareness of their negative thoughts and emotions. The study population will consist of patients admitted to the Cardiology Department of Firat University Hospital. The sample size was determined by a power analysis, with a 0.05 margin of error, a 0.95 confidence interval, and a 0.5 effect size, representing 80% of the population, resulting in 72 patients for both the experimental and control groups. Data collection tools for the study will include a Personal Information Form, the Dyspnea-12 Scale, the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scale, and the Richard-Campbell Sleep Scale. SPSS (Statistical Programme for Social Sciences) software will be used to analyze the data obtained from the study. The aim of this study is to determine the effects of a 20-minute mindfulness-based breathing exercise on dyspnea, fatigue, and sleep quality in patients with heart failure.

Low Dose Radiotherapy for Heart Failure

The primary goals of this clinical trial are to evaluate the safety and efficacy of a low dose whole-heart radiotherapy with a single fraction in ten participants with advanced heart failure.

Effect of Genetic Polymorphism on the Clinical Outcome to SGLT2 Inhibitors in Heart Failure Patients

Heart failure with reduced ejection fraction (HFrEF) is a significant cause of morbidity and mortality. Sodium-glucose co-transporter-2 (SGLT2) inhibitors have demonstrated efficacy in improving renal outcomes in patients with HFrEF. Pharmacogenetics, the study of how genetic variations influence drug response, could elucidate inter-individual variability in treatment outcomes. This study aims to assess the impact of specific genetic variants on renal outcomes in HFrEF patients treated with SGLT2 inhibitors.

Calibration of AlgoRithm for Detection of Cardiac Decompensation Via Parametric Objects (CARDCOP)

The goal of the study is to calibrate the algorithmic model of the TakeCoeur AI device to detect early heart failure decompensation in patients with heart failure, using physiological data (clinical) actively and passively collected through connected medical devices (watch, blood pressure monitor, and scale).